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WO2015160662A1 - Dispositifs de dérivation du tractus gastro-intestinal - Google Patents

Dispositifs de dérivation du tractus gastro-intestinal Download PDF

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Publication number
WO2015160662A1
WO2015160662A1 PCT/US2015/025370 US2015025370W WO2015160662A1 WO 2015160662 A1 WO2015160662 A1 WO 2015160662A1 US 2015025370 W US2015025370 W US 2015025370W WO 2015160662 A1 WO2015160662 A1 WO 2015160662A1
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WO
WIPO (PCT)
Prior art keywords
sleeve device
tube
proximal
stent
distal
Prior art date
Application number
PCT/US2015/025370
Other languages
English (en)
Inventor
Barham K. ABU DAYYEH
Original Assignee
Mayo Foundation For Medical Education And Research
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mayo Foundation For Medical Education And Research filed Critical Mayo Foundation For Medical Education And Research
Priority to US15/303,333 priority Critical patent/US10292854B2/en
Publication of WO2015160662A1 publication Critical patent/WO2015160662A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising

Definitions

  • This document relates to devices and methods for the medical treatment of conditions such as obesity and metabolic diseases.
  • this document relates to devices and methods for bypassing portions of the gastrointestinal tract to reduce weight and/or to improve diabetes control.
  • Obesity is a global problem crossing age, ethnic, and socioeconomic boundaries. In general, obesity means having too much body fat. Morbid obesity is a serious health condition that can interfere with basic physical functions such as breathing or walking. Individuals who are morbidly obese are at greater risk for illnesses including diabetes, high blood pressure, sleep apnea, gastroesophageal reflux disease, infertility, low back pain, asthma, gallstones, osteoarthritis, heart disease, and cancer. Billions of dollars are spent each year treating millions of individuals around the world suffering from such diseases. Many people suffering from morbid obesity find it nearly impossible to lose weight by controlling their diet and exercising.
  • Roux-en-Y gastric bypass is a bariatric surgical procedure that exerts its effects by bypassing the majority of the stomach and proximal small intestines; thus, excluding them from contact with nutrients. Both gastric and small intestinal components of RYGB can be useful for induction of weight loss and/or ameliorating metabolic diseases such as diabetes.
  • This document provides devices and methods for the endoscopic treatment of conditions such as obesity and metabolic diseases.
  • this document provides devices and methods for bypassing portions of the gastrointestinal (GI) tract which can result in decreased nutritional uptake, weight loss, and improvement in diabetes control.
  • the devices provided herein can be endoscopically implanted over a balloon-assisted enteroscope or over a colonoscope; such that direct visualization of the device's entire implant path and deep positioning within the small intestines can be attained in some iterations of the device.
  • the devices are distally deployed and guided to a target position endoscopically under direct endoscopic visualization.
  • a method for reducing weight and caloric uptake of a mammal comprises: inserting a sleeve device deployment system into a GI tract of the mammal; visualizing, using the endoscope, a portion of the GI tract in which the sleeve device will be deployed, including visualizing the portion of the GI tract in which the distal stent will be deployed; deploying the sleeve device such that each of the proximal and distal stents are reconfigured to have a diametrical profile that is larger than the low profile delivery configuration of each of the proximal and distal stents, and such that each of the proximal and distal stents make contact with surrounding tissue of the GI tract so as to fixate each of the proximal and distal stents in relation to the surrounding tissue of the GI tract; and withdrawing the endoscope and the over-tube while leaving the sleeve device within the GI tract.
  • the sleeve device deployment system comprises: an endoscope; an over-tube including a lumen in which at least a portion of the endoscope is disposed; and a sleeve device comprising a proximal stent, a distal stent, and a tube extending between the proximal stent and the distal stent and attached to each of the proximal and distal stents.
  • each of the proximal and distal stents are disposed on the over- tube, and wherein each of the proximal and distal stents are configured in a low profile delivery configuration during the inserting.
  • Such a method for reducing weight and caloric uptake of a mammal may optionally include one or more of the following features.
  • the mammal may be a human.
  • the method may further comprise, prior to the withdrawing, injecting a fluid into a space between the over-tube and the sleeve device.
  • the deploying may further comprise reconfiguration of the distal stent to have the diametrical profile that is larger than the low profile delivery configuration prior to reconfiguration of the proximal stent to have the diametrical profile that is larger than the low profile delivery configuration.
  • the sleeve device deployment system may be steerable, and the inserting may include steering the sleeve device deployment system within the GI tract.
  • the proximal stent may be deployed so as to make contact with surrounding tissue of the GI tract in a pyloric region of the GI tract.
  • the proximal stent may be deployed so as to make contact with surrounding tissue of the GI tract near an esophageal sphincter of the GI tract.
  • the sleeve device may further comprise one or more radiopaque markers, and fluoroscopy may be used to visualize a location of at least a portion of the sleeve device prior to the deploying.
  • the tube and each of the proximal and distal stents are configured to be disposed on the over-tube for deployment of the sleeve device and separated from the over-tube so as to deploy the sleeve device, and each of the proximal and distal stents are configurable in a low profile delivery configuration and a deployed configuration that has a diametrical profile that is larger than the low profile delivery configuration.
  • Such a sleeve device deployment system may optionally include one or more of the following features.
  • the sleeve device deployment system may be configured to deploy the sleeve device by reconfiguring the distal stent prior to reconfiguring the proximal stent.
  • the sleeve device deployment system may further comprise one or more intragastric balloons that are configured to be inflatable within a stomach of the mammal. At least a portion of an outer surface of the over-tube may be adapted to reduce friction between the over-tube and the sleeve device.
  • the devices and methods provided herein can cause weight loss and improvement in diabetes by, among other potential mechanisms, reducing the caloric intake and absorption of an individual.
  • the methods for implanting the devices can be performed endoscopically, thus avoiding the need for the more invasive open or laparoscopic surgical procedures.
  • the endoscopic technique for implanting the devices can provide total direct visualization of the GI tract anatomy in which the devices are implanted and can bypass longer segments of the gastrointestinal tract given utilization of deep enteroscopy techniques and distal release of the device.
  • each of the proximal and distal ends of the device are anchored in relation to the GI tract to definitively position the device and to provide effective migration resistance. In some embodiments, such anchoring of each of the proximal and distal ends of the device is performed during deployment either sequentially or substantially simultaneously to further enhance the definitive positioning of the device.
  • FIG. 1 illustrates an example intestinal bypass sleeve device installed in a GI tract shown in a coronal plane cross-sectional view.
  • FIG. 2 illustrates an example GI bypass sleeve device installed in a GI tract shown in a coronal plane cross-sectional view.
  • FIG. 3 illustrates another example GI bypass sleeve device installed in a GI tract shown in a coronal plane cross-sectional view.
  • FIGS. 4A-4D are a series of illustrations depicting an example deployment method that can be used to implant the bypass sleeve devices provided herein.
  • This document provides devices and methods for the medical treatment of conditions such as obesity and various metabolic diseases.
  • this document provides devices and methods for bypassing portions of the GI tract that can reduce nutritional uptake, decrease weight, and improve diabetes control.
  • the devices are fully endoscopically deployable, using substantially complete direct visualization. Some embodiments of the devices are able to bypass the stomach and small intestines and are thus able to recapitulate the physiology of RYGB.
  • the devices and methods provided herein allow the bypass of different lengths of the small intestines and/or the stomach using a distally deployed, fully endoscopic sleeve device delivery technique that utilizes single or double balloon enteroscopy, or regular enteroscopy with a colonoscope.
  • the delivery system facilitates the deployment of intestinal bypass sleeve devices of various lengths (short and long), and/or combined small intestinal and gastric bypass sleeves with or without intragastric restrictive balloons.
  • the various sleeve lengths and/or ability to bypass the stomach allows for a sequential treatment technique for induction and
  • the deployment systems and methods provided herein can deliver and anchor different lengths of sleeves and or intragastric balloons using an over-tube that is compatible with single or double balloon enteroscopes or colonoscopes.
  • This deployment system platform will allow deep small bowel insertion under endoscopic guidance with distal-to-proximal sleeve release, thus making endoscopic bypass of the stomach and placement of restrictive gastric balloons feasible, and thus closely replicating the anatomy and physiology of surgical RYGB.
  • the sleeve devices provided herein can be readily placed and removed endoscopically with procedural sedation or monitored anesthesia moderate sedation only, and on an out-patient basis. Accordingly, the devices and methods provided herein are potentially widely applicable to a large segment of the obese population with mild, moderate, and severe forms of obesity while exhibiting many advantages over bariatric surgery.
  • an example intestinal bypass sleeve device 100 can be installed in a portion of a small intestine 10 to reduce the nutritional uptake from food and liquids that pass through sleeve device 100.
  • sleeve device 100 at least partially blocks food and liquids from contacting the portion of small intestine 10 in which sleeve device 100 resides and prevents mixing of food with digestive pancreas and biliary secretions until later in the gastrointestinal tract Consequently, the nutritional uptake from food and liquids can be reduced by the presence of sleeve device 100 and only partially digested nutrients delivered to the distal gastrointestinal tract.
  • a proximal end 1 10 of sleeve device 100 is positioned in the patient's pyloric region at the junction between small intestine 10 and stomach 20.
  • proximal end 110 can be located at other locations within small intestine 10 or stomach 20.
  • Sleeve device 100 includes proximal end 110, a distal end 120, and a tube 130.
  • Tube 130 extends between proximal end 1 10 and distal end 120 and is attached to each of proximal end 110 and distal end 120.
  • Tube 130 can be constructed from a biocompatible flexible polymer such as, but not limited to, silicone, ePTFE, and the like, and combinations of such materials.
  • tube 130 is constructed with a wall that is thin and flexible so that peristalsis can occur from forces delivered by small intestine 10 through tube 130.
  • the diameter of tube 130 is slightly less than the inner diameter of small intestine 10 and is consistent along its entire length. However, in some embodiments the diameter of tube 130 may vary along its length.
  • tube 130 is impermeable to body fluids and ingested food/liquids. However, in some embodiments, some or all of tube 130 can be porous or semipermeable. In some embodiments, tube 130 includes coatings on at least portions of its interior and/or exterior walls. For example, in some such embodiments the coatings can be included to increase the chemical resistance of tube 130, or to resist infection and/or reduce the potential for tissue inflammatory response. Further, in some embodiments at least portions of the interior and/or exterior of tube 130 are coated with a lubricious coating to reduce friction related to food passing though tube 130.
  • tube 130 includes one or more holes 132 (openings through the wall of tube 130) in some locations, such as the distal portion of tube 130.
  • holes 132 can advantageously allow pancreaticobiliary secretions to enter tube 130 and to mix with food contents therein for partial digestion.
  • Sleeve device 100 also includes proximal end 1 10 and distal end 120.
  • proximal end 1 10 and distal end 120 each include stent devices 112 and 122 respectively.
  • Tube 130 can be attached to stent devices 1 12 and 122 using various techniques such as, but not limited to, crimping, clamping, suturing, heat staking, using adhesives, and the like.
  • stent devices 112 and 122 can be self-expanding stents made from materials such as, but not limited to, nitinol, stainless steel, and the like, and combinations of such materials.
  • stent devices 112 and 122 are frustoconical in shape (flared). As such, migration resistance of stent devices 1 12 and 122 can be enhanced in some implementations.
  • one or both of stent devices 1 12 and 122 are shaped differently, such as, but not limited to, cylindrically, toroidally, and the like.
  • one or both of stent devices 1 12 and 122 can include supplemental anchor features 114 and 124 respectively.
  • anchor features 1 14 and 124 can be items such as, but not limited to, barbs, hooks, needles, atraumatic protrusions, and the like, and combinations thereof.
  • one or both stent devices 1 12 and 122 can be secured to surrounding tissue by one or more endoscopically installed sutures.
  • stent device 1 12 at proximal end 110 can have about three or four sutures installed to secure stent device 1 12 in the pyloric region.
  • one or both of stent devices 1 12 and 122 can include one or more radiopaque markers to assist a clinician to fluoroscopically visualize sleeve device 100 during the deployment process.
  • radiopaque markers can be comprised of materials such as, but not limited to, platinum, tungsten, tantalum, palladium alloys, and the like, and combinations thereof.
  • an example GI bypass sleeve device 200 can be installed in a portion of small intestine 10 and in stomach 20 to reduce the nutritional uptake from food and liquids that pass through sleeve device 200.
  • sleeve device 200 at least partially blocks food and liquids from contacting the portion of small intestine 10 and stomach 20 in which sleeve device 200 resides.
  • a proximal end 210 of sleeve device 200 is positioned near the esophageal sphincter at the junction of esophagus 30 and stomach 20.
  • proximal end 210 can be located at other locations within small intestine 10, stomach 20, or esophagus 30.
  • Sleeve device 200 includes proximal end 210, a distal end 220, a first tube portion 230, and a second tube portion 240. Tube portions 230 and 240 extend between proximal end 210 and distal end 220 and are attached at each of proximal end 210 and distal end 220.
  • first tube portion 230 extends from proximal end 210 to the pyloric region
  • second tube portion 240 extends from the distal end of first tube portion 230 in the pyloric region to distal end 220.
  • Tube portions 230 and 240 can be constructed from a biocompatible flexible polymer as described above in reference to tube 130. In some embodiments, tube portions 230 and 240 are constructed uniformly in relation to each other. However, in some embodiments tube portions 230 and 240 are constructed dissimilarly. For example, in some embodiments first tube portion 230 may be constructed to be more rigid than second tube portion 240. In some such examples, first tube portion 230 may have a wall that is thicker than second tube portion 240, or may be made of a material that is less flexible than second tube portion 240.
  • Sleeve device 200 also includes proximal end 210 and distal end 220.
  • proximal end 210 and distal end 220 each include stent devices 212 and 222 respectively.
  • First tube portion 230 can be attached to stent device 212 and second tube portion 240 can be attached to stent device 222 using various techniques such as, but not limited to, crimping, clamping, suturing, using adhesives, and the like.
  • stent devices 212 and 222 can be self-expanding stents made from materials such as, but not limited to, nitinol, stainless steel, and the like, and combinations of such materials.
  • stent devices 212 and 222 are frustoconical in shape (flared). As such, migration resistance of stent devices 212 and 222 can be enhanced in some implementations.
  • one or both of stent devices 212 and 222 are shaped differently, such as, but not limited to, cylindrically, toroidally, and the like.
  • one or both of stent devices 212 and 222 can include supplemental anchor features as described above in regard to anchor features 114 and 124 respectively.
  • one or both stent devices 212 and 222 can be secured to surrounding tissue by one or more endoscopically installed sutures.
  • stent device 212 at proximal end 210 can have about three or four sutures installed to secure stent device 212 near the esophageal sphincter.
  • one or both of stent devices 212 and 222 can include one or more radiopaque markers as described above in regard to stent devices 1 12 and 122.
  • another example GI bypass sleeve device 300 can be installed in a portion of small intestine 10 and in stomach 20 to reduce the nutritional uptake from food and liquids that pass through sleeve device 300.
  • sleeve device 300 at least partially blocks food and liquids from contacting the portion of small intestine 10 and stomach 20 in which sleeve device 300 resides.
  • a proximal end 310 of sleeve device 300 is positioned near the esophageal sphincter at the junction of esophagus 30 and stomach 20.
  • proximal end 310 can be located at other locations within small intestine 10, stomach 20, or esophagus 30.
  • Sleeve device 300 includes proximal end 310, a distal end 320, a first tube portion 330, and a second tube portion 340.
  • Tube portions 330 and 340 extend between proximal end 310 and distal end 320 and are attached at each of proximal end 310 and distal end 320.
  • first tube portion 330 extends from proximal end 310 to the pyloric region
  • second tube portion 340 extends from the distal end of first tube portion 330 in the pyloric region to distal end 320.
  • GI bypass sleeve device 300 is analogous to sleeve device 200 but with the addition of one or more intragastric balloons 332 that are coupled with first tube portion 330.
  • three intragastric balloons 332 are included.
  • the one or more intragastric balloons 332 can be of differing sizes in some embodiments.
  • intragastric balloons 332 are of three different sizes (small in the gastric antrum, medium in the gastric body, and large in the gastric fudus). Other configurations are also envisioned.
  • the one or more intragastric balloons 332 will serve at least three purposes: (1) to support the weight of the food bolus in first tube portion 330 without exerting excessive stress on stent device 312; (2) to be an anti-migration mechanism; and (3) to provide gastric restriction for effective weight loss.
  • each of the one or more intragastric balloons 332 includes an inflation port 334.
  • Inflation port 334 can be a septum, a one-way valve, and the like, and combinations thereof.
  • An endoscopic needle can be used to inflate the one or more intragastric balloons 332 via the inflation ports 334 in situ.
  • a diagnostic gastroscope can be re-introduced in the inner lumen of first tube portion 330.
  • inflation ports 334 are visually marked using colors or labels, for example, so that inflation ports 334 can be readily identified
  • Radiopaque markers can also be included in some embodiments.
  • a 25 gauge needle for example, can then be used to pass through the inflation ports 334 (one at a time).
  • An inflation medium such as air for example, can then be injected into intragastric balloons 332.
  • This configuration also allows for endoscopic adjustment of the volumes of intragastric balloons 332 during the course of treatment.
  • the volumes of intragastric balloons 332 can be tailored with respect to patient satiety levels and weight loss during the course of treatment.
  • Tube portions 330 and 340 can be constructed from a biocompatible flexible polymer as described above in reference to tube 130. In some embodiments, tube portions 330 and 340 are constructed uniformly in relation to each other. However, in some embodiments tube portions 330 and 340 are constructed dissimilarly. For example, in some embodiments first tube portion 330 may be constructed to be more rigid than second tube portion 340. In some such examples, first tube portion 330 may have a wall that is thicker than second tube portion 340, or may be made of a material that is less flexible than second tube portion 340.
  • Sleeve device 300 also includes proximal end 310 and distal end 320.
  • proximal end 310 and distal end 320 each include stent devices 312 and 322 respectively.
  • First tube portion 330 can be attached to stent device 312 and second tube portion 340 can be attached to stent device 322 using various techniques such as, but not limited to, crimping, clamping, suturing, heat staking, using adhesives, and the like.
  • stent devices 312 and 322 can be self-expanding stents made from materials such as, but not limited to, nitinol, stainless steel, and the like, and combinations of such materials.
  • stent devices 312 and 322 are frustoconical in shape (flared). As such, migration resistance of stent devices 312 and 322 can be enhanced in some implementations.
  • one or both of stent devices 312 and 322 are shaped differently, such as, but not limited to, cylindrically, toroidally, and the like.
  • one or both of stent devices 312 and 322 can include supplemental anchor features as described above in regard to anchor features 114 and 124 respectively.
  • one or both stent devices 312 and 322 can be secured to surrounding tissue by one or more endoscopically installed sutures.
  • stent device 312 at proximal end 310 can have about three or four sutures installed to secure stent device 312 near the esophageal sphincter.
  • one or both of stent devices 312 and 322 can include one or more radiopaque markers as described above in regard to stent devices 1 12 and 122.
  • the Gl/intestinal bypass sleeve devices provided herein can be implanted endoscopically using deployment system 400, for example.
  • intestinal bypass sleeve device 100 is the device illustrated as being endoscopically implanted by deployment system 400.
  • the same general techniques that are used to endoscopically implant intestinal bypass sleeve device 100 can also be used to implant any of the other Gl/intestinal bypass sleeve devices provided herein.
  • Deployment system 400 includes a scope device 410 and an over-tube 420.
  • Over-tube 420 includes a lumen in which scope device 410 is slidably disposed.
  • Intestinal bypass sleeve device 100 is releasably coupled on the outer surface of a portion of over-tube 420.
  • at least stent devices 112 and 122 are releasably coupled by a friction fit to the outer diameter of a portion of over-tube 420 (when the stent devices 1 12 and 122 are in a diametrically constrained delivery configuration as shown in FIG. 4A).
  • a distal end portion 412 of scope device 410 can extend near to or protrude beyond a distal tip 425 of over-tube 420.
  • deployment system 400 is advanced into the patient (e.g., through the esophagus 30, stomach 20, and a portion of small intestine 10) to arrive at the configuration shown or at one that is similar to what is shown, the clinician operator can directly visualize the patient's relevant anatomical features that will be affected by sleeve device 100.
  • At least distal end portion 412 is steerable by a clinician operator of deployment system 400.
  • deployment system 400 when deployment system 400 is being advanced into the patient (e.g., through the esophagus 30, stomach 20, and a portion of small intestine 10) to arrive at the configuration shown or at one that is similar to what is shown, the clinician operator can actively steer/drive the distal end portion 412 of scope device 410.
  • the clinician can drive/steer distal tip 425 of over-tube 420 as well as distal reiterate, distal end 120 of sleeve device 100 can be steered/driven to a target anatomical location in small intestine 10 under complete direct visualization by a clinician operator using deployment system 400.
  • one or more radiopaque markers may be included at one or more locations on sleeve device 100.
  • the depicted embodiment of sleeve device 100 includes radiopaque markers 1 16 on proximal stent device 1 12.
  • radiopaque markers 116 can be used to assist with fluoroscopic visualization of the location of proximal end 110 so that stent device 1 12 can be deployed (expanded) in a target location.
  • Over-tube 420 includes one or more balloon members 424 adjacent to distal tip 425 of over-tube 420. Similar to single or double balloon enteroscopy, this balloon can retract (accordion) the small bowel to allow deeper delivery of longer sleeves if desired. Furthermore, upon arrival of distal end portion 412 of scope device 410 in a target location within small intestine 10, one or more balloon member 424 can be inflated to temporarily anchor the distal portion of deployment system 400 within small intestine 10. Such is the configuration shown in FIG. 4A.
  • stent devices 1 12 and 122 can be deployed (expanded) by a clinician operator when sleeve device 100 is located within the patient's anatomy at a desired location and in a desired configuration.
  • stent devices 1 12 and 122 are initially constrained in a low- profile delivery configuration on the over-tube 420 when the deployment system 400 is driven into the desired location.
  • an actuator 426 e.g., a wire
  • stent devices 112 and 122 Upon release of their constraints, stent devices 112 and 122 can self- expand to conform to the surrounding tissue, and to thereby anchor the proximal end 1 10 and distal end 120 of sleeve device 100 in relation to the Gl/intestinal anatomy of the patient. In addition, expansion of stent devices 112 and 122 decouples sleeve device 100 from over-tube 420. However, at this stage over-tube 420 remains within sleeve device 100 as shown.
  • the actuator 426 is a wire that runs the length of over-tube 420 and exits from a port 421 of over-tube 420. Pulling wire 426 releases the diametrical constraints on stent devices 1 12 and 122.
  • delivery system 400 is configured such that stent devices 112 and 122 have individual
  • delivery system 400 is configured such that stent devices 112 and 122 have a common actuator 426 whereby stent devices 112 and 122 can be deployed either simultaneously or sequentially by manipulation of the common actuator 426.
  • Such removal steps can include, for example: (i) deflation of balloon member 424, (ii) injection of a fluidic lubricant 427 into port 422 of over-tube 420, (iii) withdrawal of scope device 410 from within over-tube 420, and (iv) withdrawal of over-tube 420 from within sleeve device 100. It is not necessarily required in all implementations to perform those removal steps in the order listed. Nor is each of those removal steps necessarily required in all implementations.
  • fluidic lubricant 427 into port 422 of over-tube 420 assists the process of deploying sleeve 100 by, for example: (i) diametrically expanding tube 130 of sleeve 100 and (ii) reducing friction between the outer surface of over-tube 420 and inner surface of tube 130.
  • fluids such as, but not limited to, water, saline, and the like can be used as fluidic lubricant 427.
  • Fluid lubricant 427 can be injected into a port 422 of over-tube 420. From port 422, one or more lumens in over-tube 420 can convey fluid lubricant 427 distally within over-tube 420.
  • the outer surface of over-tube 420 can include one or more openings 428 through which fluid lubricant 427 can flow so as to exit over-tube 420 and enter into the space between over-tube 420 and sleeve device 100.
  • At least some portions of the surface of over-tube 420 are treated to reduce friction between over-tube 420 and sleeve device 100.
  • a hydrophilic coating such as having four thin hydrophilic coated lines spanning the outer surface of the overtube (one on each outer quadrant), can be disposed on at least some portions of the outer surface of over-tube 420.
  • Such a feature, along with fluid lubricant 427, can facilitate a substantially frictionless withdrawal of over-tube 420 from sleeve device 100 without materially affecting the deployed configuration and location of sleeve device 100 within the patient.
  • the Gl/intestinal bypass sleeve devices provided herein are readily removable endoscopically.
  • a long wire on the distal stent is grasped by an endoscopic forceps (from within the tube of the sleeve device) and pulled into the endoscope working channel. This will at least partially diametrically collapse the distal stent.
  • the small intestinal sleeve is then inverted into the stomach by withdrawal of the endoscope and wire. Once in the stomach, the tube is cut in the middle by a cutting snare or endoscopic scissors.
  • the distal stent wire (which is everted into the stomach) is grasped again by an endoscopic forceps and pulled into the working channel of the endoscope to constrain and pull the cut half of the tube/sleeve. Once this half is pulled the scope is re-introduced in the stomach and the wire of the proximal stent is grasped and pulled into the working channel of a gastroscope to constrain and remove the second cut half of the tube/sleeve.
  • Removal of GI bypass sleeve devices can be performed as follows.
  • the gastric balloons (if present) are deflated endoscopically by an endoscopic needle as described above.
  • the distal stent wire is grasped and constrained by a forceps into the working channel of the endoscope and the small intestinal tube is inverted into the gastric tube.
  • the proximal stent wire is grasped and constrained by a forceps into the working channel of the endoscope and then the entire sleeve device is pulled out of the patient's mouth.
  • the use of an esophageal length over-tube for removal of the GI sleeve device is optional.

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Abstract

La présente invention concerne des dispositifs et des procédés pouvant être utilisés pour le traitement endoscopique d'états tels que l'obésité et des maladies métaboliques. Par exemple, la présente invention concerne des dispositifs et des procédés permettant de dériver des parties du tractus gastro-intestinal pour réduire l'apport nutritionnel. Les dispositifs de l'invention peuvent être implantés par voie endoscopique, de telle sorte que la visualisation directe de la totalité du site de l'implant dans le tractus gastro-intestinal est atteinte. Dans certains modes de réalisation, le dispositif est déployé de manière distale à l'aide d'une technique qui est similaire à celle de l'entéroscopie à simple ou à double ballonnet.
PCT/US2015/025370 2014-04-14 2015-04-10 Dispositifs de dérivation du tractus gastro-intestinal WO2015160662A1 (fr)

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US15/303,333 US10292854B2 (en) 2014-04-14 2015-04-10 Gastrointestinal tract bypass devices

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US201461979203P 2014-04-14 2014-04-14
US61/979,203 2014-04-14

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FR2978345B1 (fr) 2011-07-25 2013-08-30 Charam Khosrovaninejad Dispositif chirurgical d'ancrage controle dans l'intestin.
US10507128B2 (en) * 2015-11-17 2019-12-17 Boston Scientific Scimed, Inc. Devices and methods for reducing absorption
FR3072557B1 (fr) 2017-10-19 2019-11-08 Safeheal Dispositif chirurgical complexe pour la realisation et protection d'une anastomose.
US12161574B2 (en) 2019-06-14 2024-12-10 Mayo Foundation For Medical Education And Research Methods and devices for gastricintestinal tract bypass
US12239321B2 (en) 2023-03-17 2025-03-04 SafeHeal SAS Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis

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EP1750595A4 (fr) 2004-05-07 2008-10-22 Valentx Inc Dispositifs et méthodes pour arrimer un implant endolumenal gastro-intestinal
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US20040039452A1 (en) * 2002-08-26 2004-02-26 Marc Bessler Endoscopic gastric bypass
US20130079603A1 (en) * 2009-09-29 2013-03-28 IBIS Medical, Inc. Intragastric implant devices

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US20170027729A1 (en) 2017-02-02

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